Real World Experiences: Pirfenidone and Nintedanib are Effective and Well Tolerated Treatments for Idiopathic Pulmonary Fibrosis
Tóm tắt
Idiopathic Pulmonary Fibrosis (IPF) now has two licensed treatments available. Pirfenidone was the first drug to be licensed and approved for use, followed by nintedanib. We set out our real world experience with these agents in terms of their adverse events profile outside the restrictions of a clinical trial. We have demonstrated in the real world setting, that side effects are common and predominantly gastrointestinal with both therapies. Our study shows that the side effects can be effectively managed in the majority of patients with an acceptable discontinuation rate similar to that seen in the clinical trials. These findings are compelling despite the fact that the patients in our study are older, have severer disease as depicted by baseline lung function and more co-morbidities. Our data provides ongoing evidence of the safety and tolerability of both pirfenidone and nintedanib in patients who would not have met the rigorous criteria to be included in a clinical trial. Both these agents are effective in the management of IPF and slow the progression of this debilitating life limiting condition.
Từ khóa
Tài liệu tham khảo
Ley, 2011, Clinical Course and Prediction of Survival in Idiopathic Pulmonary Fibrosis, Am. J. Respir. Crit. Care Med., 183, 431, 10.1164/rccm.201006-0894CI
Raghu, 2015, An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis. An Update of the 2011 Clinical Practice Guideline, Am. J. Respir. Crit. Care Med., 192, e3, 10.1164/rccm.201506-1063ST
National Institute for Health and Care Excellence (2013). NICE Guideline (CG163), National Institute for Health and Care Excellence.
National Institute for Health and Care Excellence (2013). NICE Technology Appraisal Guidance (TA282), National Institute for Health and Care Excellence.
National Institute for Health and Care Excellence (2016). NICE Technology Appraisal Guidance (TA379), National Institute for Health and Care Excellence.
Noble, 2011, Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): Two randomised trials, Lancet, 377, 1760, 10.1016/S0140-6736(11)60405-4
King, 2014, A Phase 3 Trial of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis, N. Engl. J. Med., 370, 2083, 10.1056/NEJMoa1402582
Coward, 2010, The pathogenesis of idiopathic pulmonary fibrosis, Ther. Adv. Respir. Dis., 4, 367, 10.1177/1753465810379801
Richeldi, 2011, Efficacy of a tyrosine kinase inhibitor in idiopathic pulmonary fibrosis, N. Engl. J. Med., 365, 1079, 10.1056/NEJMoa1103690
Richeldi, 2014, Efficacy and Safety of Nintedanib in idiopathic pulmonary fibrosis, N. Engl. J. Med., 370, 2071, 10.1056/NEJMoa1402584
Chaudhuri, 2014, Real world experiences: Pirfenidone is well tolerated in patients with idiopathic pulmonary fibrosis, Respir. Med., 108, 224, 10.1016/j.rmed.2013.11.005
Wijsenbeek, 2015, Early Experience of Pirfenidone in Daily Clinical Practice in Belgium and The Netherlands: A Retrospective Cohort Analysis, Adv. Ther., 32, 691, 10.1007/s12325-015-0225-1
Costabel, 2014, Analysis of lung function and survival in RECAP: An open-label extension study of pirfenidone in patients with idiopathic pulmonary fibrosis, Sarcoidosis Vasc. Diffus. Lung Dis., 31, 198
The British Thoracic Society Interstitial Lung Disease Registry Programme Annual Report 2014/15. Available online: https://www.brit-thoracic.org.uk/document-library/audit-and-quality-improvement/lung-disease-registry/bts-ild-registry-programme-annual-report-201415/.
Costabel, 2014, Pirfenidone in Idiopathic Pulmonary Fibrosis: Expert Panel Discussion on the Management of Drug-Related Adverse Events, Adv. Ther., 31, 375, 10.1007/s12325-014-0112-1
Cottin, 2014, Diagnosis and Management of Idiopathic Pulmonary Fibrosis: French practical guidelines, Eur. Respir. Rev., 23, 193, 10.1183/09059180.00001814
Edwards, 2000, Adverse drug reactions, definitions, diagnosis and management, Lancet, 356, 1255, 10.1016/S0140-6736(00)02799-9
Mazzei, 2015, Nintedanib in the treatment of idiopathic pulmonary fibrosis, Ther. Adv. Respir. Dis., 9, 121, 10.1177/1753465815579365
Drucker, 2011, Drug-Induced Photosensitivity, Culprit drugs, management and prevention, Drug Saf., 34, 821, 10.2165/11592780-000000000-00000